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CTRI Number  CTRI/2024/08/072092 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Educating children and parents to improve dental visits - a research for social benefit.  
Scientific Title of Study   Effectiveness of a school based oral health education and screening program in stimulating dental attendance of children - A Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya Mahadev Pattanshetti 
Designation  post graduate student 
Affiliation  SDM College of dental sciences and hospital, Dharwad 
Address  department of public health dentistry SDM College of dental sciences and hospital, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9740274809  
Fax    
Email  priyapattanshetti183@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravi Shirahatti  
Designation  professor and HOD of public health dentistry  
Affiliation  SDM college of dental sciences and hospital 
Address  department of public health dentistry, SDM college of dental sciences and hospital

Dharwad
KARNATAKA
580009
India 
Phone  7259229908  
Fax    
Email  shirahattiravi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Shirahatti  
Designation  professor and HOD of public health dentistry  
Affiliation  SDM college of dental sciences and hospital 
Address  department of public health dentistry, SDM college of dental sciences and hospital

Dharwad
KARNATAKA
580009
India 
Phone  7259229908  
Fax    
Email  shirahattiravi@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, SDM College of Dental sciences, Dharwad will oversee and provide infrastructural and other support (transport, equipment, manpower) for this trial.  
 
Primary Sponsor  
Name  Dr Priya Mahadev Pattanshetti 
Address  II year postgraduate student Department of public health Dentistry, SDM College of dental sciences and hospital, Dharwad 580009 India. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priya Mahadev Pattanshetti  SDM college dental sciences and hospital  room no. 10 Department of Public health Dentistry
Dharwad
KARNATAKA 
9740274809

priyapattanshetti183@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  improvised protocol   improvised protocol - video based online communication or telephonic communication of parents to educate parent  
Comparator Agent  traditional referral  oral examination, oral health education and issue of referral cards to children . in the referral cards the childs oral findings and treatment required would be mentioned and will be asked to visit the nearest dentist or our institution for obtaining the treatment 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children aged 7 to 12 years at baseline
2.Permission will be obtained for conducting the oral health education and screening at school and permission from the authority will be considered as a consent. We have applied for “wavier of consent” for individuals. However each child’s oral assent will be obtained and examination will be carried out only for the assenting children
3.Phone number of the parent / guardian is available with the child or with the school authorities.
 
 
ExclusionCriteria 
Details  1.children with any mentally compromised condition such as congenital heart disease, hematological conditions, immune deficiency disease, and end stage renal disease that might modify the time taken for initiation of treatment
2.children who refuse to participate in the study
3.children scheduled for ongoing dental treatment  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
(a) the rate of dental attendance following improvised screening protocol.
(b) the rate of dental attendance following traditional school based oral screening.
(c) compare the rate of dental attendance following improvised screening protocol with traditional school based oral screening.
 
3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.the factors associated with rate of dental attendance
(demographic factors , type of treatment needed, distance from the Dental institution, dental attendance & experience of parents )
2. the prevalence of dental caries gingival bleeding dental fluorosis ,developmental defects of tooth dental trauma amongst the school going children.
 
3 months 
1.To analyze the factors associated with rate of dental attendance
(demographic factors , type of treatment needed, distance from the Dental institution, dental attendance & experience of parents )
2.To determine the prevalence of dental caries gingival bleeding dental fluorosis ,developmental defects of tooth dental trauma amongst the school going children.
 
3 months 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In Karnataka , the percentage of subjects with caries experience of dmft ranges from about 53.4 per cent in 5 year children  and DMFT of about 39.1  per cent in 12 year old children. Unfortunately, the habit of routine dental visits is not common in our population. Majority of dental visits are undertaken only after the child gets pain or has extensive decay. School based dental screening programs are recommended by the WHO. A modification in the present School-based dental screening that incorporates more effective communication between the dentist and parent could potentially improve uptake of dental services. In our modified method of communication to the parent after screening, we plan to improve the involvement of parent with help of video based communication, customized health education and telephonic reminders to stimulate attendance. Hence we plan to compare the effectiveness of two alternative approaches for school-based dental screening in promoting dental attendance and reducing untreated dental caries among primary school children.

The study will be conducted among school-going children of Dharwad city who are aged between 7 and 12 years. From 10 schools selected, 100 children will dental screened to meet a quota of at-least 70 children ( total of 700 in 10 schools). stratified random selection will be done to select 140 children who will receive improvised screening protocol. All the 700 children will be visited after 3 months from the date of screening for confirming whether the child completed the dental visit and also about the dental treatments undertaken. Comparison of rate of dental attendance following improvised screening protocol with traditional school based oral screening will be done.recruitment is planned to begin from 15th of July and the follow up is expected to be completed by 15th January 2025 (subject to CTRI registration prior to 15th July 2024 )

 
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